Operator's Manual
Table Of Contents
- 1. Introduction
- 1.1. Introduction
- 1.2. Safety Information
- 1.3. Device Description
- 1.4. Intended Purpose
- 1.5. BIS™ Advance Monitor System Indications and Contraindications
- 1.6. Patient Target Groups
- 1.7. Intended Users
- 1.8. Essential Performance
- 1.9. Adverse Events (Residual Risks)
- 1.10. The BIS™ Advance Parameters
- 1.11. Symbols
- 2. The BIS™ Advance Monitor — Equipment and Supplies
- 2.1. The BIS™ Advance System
- 2.2. Parts of the System
- 3. Installation and Preparation for Use
- 3.1. Operating Environment
- 3.2. Power Requirements and Battery Use
- 3.3. Battery Operation
- 3.4. Mounting the Docking Station
- 3.5. Preparing the Docking Station
- 3.6. Preparing the Monitor
- 3.7. Home Screen
- 3.8. Four-Channel Monitoring
- 3.9. Home Screen Trend Graphs
- 3.10. Home Screen Numeric Section
- 3.11. Home Screen Menus
- 3.12. Home Screen Options
- 3.13. Secondary Trend Selection
- 3.14. Home Screen Audio Alarm Settings
- 3.15. Settings and Maintenance
- 3.16. Info Options
- 3.17. Quick Reference Checklist
- 4. Operating the BIS™ Advance Monitoring System
- 4.1. Preparing for Operation
- 4.2. Cases
- 4.3. Alarms and Messages
- 4.4. Chart Data
- 4.5. Menu Map
- 4.6. Institutional Settings
- 5. Data Storage, Transfer, and Export
- 5.1. Cybersecurity and Data Integrity
- 5.2. Monitor Data Memory
- 5.3. BISx Data Memory
- 5.4. Types of Exported Data
- 5.5. Live Case Export
- 5.6. Saved Cases Export
- 5.7. Recording a Snapshot Event
- 5.8. BIS™ Saved Data Files
- 5.9. Logs Export
- 5.10. Viewing and Printing Saved Data in PDF Format
- 6. Service and Maintenance
- 6.1. Introduction
- 6.2. Servicing the BIS™ Advance Monitor
- 6.3. Battery Handling
- 6.4. Cleaning the BIS™ Advance Monitor
- 6.5. Instrument Identification
- 7. Diagnostics and Troubleshooting
- 7.1. Diagnostics
- 7.2. Troubleshooting
- 7.3. Administrator Mode
- 7.4. Demo Mode
- 7.5. Glossary
- 7.6. Specifications
- 7.6.1. General Specifications
- 7.6.2. Operating Environments
- 7.6.3. Power Supply
- 7.6.4. Battery Specifications
- 7.6.5. Controls and Connectors
- 7.6.6. Alarms
- 7.6.7. Display
- 7.6.8. Sound Pressure Data
- 7.6.9. BIS Specifications
- 7.6.10. EEG Specifications
- 7.6.11. BISx Module Specifications
- 7.6.12. Software/GUI Specifications
- 7.7. Electromagnetic Compatibility Specifications
- 7.8. Product Compliance
- 7.9. BIS™ Advance Components, Accessories, and Documentation
- 7.10. Warranty
- 7.11. Software License Agreement
Device Description
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BIS™ Advance Monitor
patient's level of hypnosis. The device is for use by medical personnel only. The
monitor and the BISx unit are designed for use for multiple patients, multiple uses.
The BIS™ Advance monitor display consists of:
• The current BIS™ number
• Raw EEG waveforms in real time
• Various signal quality indicators (EMG, SQI)
• Trend graphs of processed EEG variables
• Processed EEG variables, including suppression ratio (SR), suppression time
(ST), and burst count (the latter available when a 4-channel BIS™ system
and a BIS™ bilateral sensor or an Extended sensor are in use)
• Alarm Indicators and Messages
The system shall perform computations on the acquired EEG signals in order to
produce the following processed variables in addition to the BIS™ number:
• Electromyography (EMG)
• Signal Quality Index (SQI)
• Suppression Ratio (SR)
• Burst Count - for Extend Sensor and four-channel monitoring only (BURST)
• Suppression Time (ST)
• Spectral Edge Frequency (SEF)
• Median Frequency (MF)
• EEG Power Asymmetry Index (ASYM) (for four-channel monitoring only)
The BIS™ Advance monitor can work with a BISx module, which records and displays
two channels of patient EEG information, or with a BISx4 module, which records and
displays four channels of EEG, two from each side of the brain. For more information
about the four-channel system, listing the unique aspects of four-channel
monitoring, reference 3.8 Four-Channel Monitoring on page 92.